Cleared Traditional

K092889 - SYNTEC OSTEO-PLATE AND SCREW FIXATION

K092889 is an FDA 510(k) clearance for SYNTEC OSTEO-PLATE AND SCREW FIXATION, manufactured by Syntec Scientific Corp.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K092889 · Syntec Scientific Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
277d
Days
Class 2
Risk

K092889 is an FDA 510(k) clearance for the SYNTEC OSTEO-PLATE AND SCREW FIXATION. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Syntec Scientific Corp. (Taipei City, TW). The FDA issued a Cleared decision on June 25, 2010 after a review of 277 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Syntec Scientific Corp. devices

FDA 510(k) Submission Details - K092889

510(k) Number K092889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2009
Decision Date June 25, 2010
Days to Decision 277 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 122d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1053
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K092889.
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776 · Synthes (Usa) · Aug 2010
ASCENSION TOTAL PLATE SYSTEM
K100502 · Ascension Orthopedics, Inc. · Aug 2010
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240 · DePuy Orthopaedics, Inc. · Jul 2010
ASCENSION ANKLE FUSION PLATE SYSTEM
K100176 · Ascension Orthopedics, Inc. · Jun 2010
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708
K101421 · DePuy Orthopaedics, Inc. · Jun 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240 · OrthoPediatrics Corp. · May 2010